News

Medical research under threat after Alder Hey scandal

Mark Hunter, Leeds

Uncertainty over the legal and ethical implications of retaining human tissue is endangering several medical research programmes, leaving pathologists "in a hiatus" over the status of archived slides and tissue blocks, and putting postmortem diagnoses back 30 years, it was claimed this week.

In the aftermath of the damning report into the retention of children's organs at Alder Hey Hospital in Liverpool, researchers and pathologists are growing increasingly concerned that a combination of public distrust and government overreaction could severely restrict the supply of human tissue.

Of particular concern is the uncertainty over what constitutes fully informed patient consent. Advice from the chief medical officer, Liam Donaldson, after the Alder Hey and Bristol interim inquiry reports, stated that consent forms should contain "details of the tissue and organs to be retained, the uses to which they might be put, and the agreed length of time for retention."

Professor Gordon McVie, director general of the Cancer Research Campaign, told the BMJ that, although researchers remained "extremely sensitive to the issue of patient consent," it was unreasonable to expect scientists to list every use a tissue sample might be put to.

"It's impossible to predict everything you are going to do. There are 3000 genes linked to breast cancer. Are you going to list them all on a consent form?"

Professor McVie expressed concern that plans to create banks of excised tumour tissue to aid cancer research could be put at risk if collection of the tissue was restricted.

Professor James Lowe, head of neuropathology at the University of Nottingham, said that restrictions on retaining tissue after a coroner's postmortem examination could have serious consequences for the diagnosis of a wide range of diseases. "It is good practice to confirm the postmortem diagnosis by histology. But we are no longer doing that because recent interpretations of the law now imply that tissues cannot be retained once the coroner has given a cause of death."

As a result, it might never be discovered if a lung cancer could be attributed to asbestos. Creutzfeldt-Jakob disease, Alzheimer's disease, and alcoholism are now all diagnosed simply as dementia, and epidemiological research into the real causes of sudden death is practically impossible. "We are going back to the days when the cause of death was determined on first sight rather than by checking down the microscope," said Professor Lowe.

Professor Phil Quirke, head of histopathology at Leeds Teaching Hospitals NHS Trust, pointed out that thousands of slides and tissue blocks were currently held in hospitals as part of patients' medical records. These samples were invaluable in cases where the original diagnosis was challenged, where there was a genetic basis to the disease, or where new potential treatments became available. It was unclear, however, whether the consent obtained before the scandal at Alder Hey would stand up to current scrutiny.

"We desperately need guidance on this," said Professor Quirke. "We don't know whether we should continue cataloguing the tissue, or whether we should try to obtain patient consent retrospectively."